Paracetamol 500mg Tablet
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg paracetamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White capsule-shaped tablets, scored on one side. The score line is not intended for breaking the tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Paracetamol is a mild analgesic and antipyretic. It is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat, and for relieving the fever, aches and pains of colds and flu.
Also recommended for the symptomatic relief of pain due to non-serious arthritis.
4.2 Posology and method of administration
Posology
Adults:
2 tablets up to four times daily as required.
These doses should not be repeated more frequently than every four hours nor should more than 4 doses be given in any 24-hour period.
Children aged 10 - 15 years:
One tablet every 4-6 hours when necessary to a maximum of 4 doses in 24 hours.
Children under 10 years:
Not recommended.
Alternative presentations of paracetamol are recommended for paediatric usage in order to obtain suitable doses.
Method of administration
Oral administration only.
4.3 Contraindications
Hypersensitivity to paracetamol or any of the other excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with impaired renal or hepatic function. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Do not exceed recommended dose.
Patients should be advised not to take other paracetamol-containing products concurrently.
Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.
Patients should be advised to consult their doctor if their headaches become persistent.
If symptoms persist the patient should consult his/her doctor.
Keep out of the sight and reach of children.
Pack Label:
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Do not take with any other paracetamol-containing products.
Patient Information Leaflet:
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
4.5 Interaction with other medicinal products and other forms of interaction
Hepatotoxicity is enhanced by alcohol, phenobarbitone and doxorubicin. Paracetamol increases blood concentrations of aspirin.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
4.6 Fertility, pregnancy and lactation
Pregnancy
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
Breast feeding
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.
4.7 Effects on ability to drive and use machines
Paracetamol has no influence on the ability to drive and use machines.
4.8 Undesirable effects
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post- marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post- marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
Post marketing data:
|
Body System |
Undesirable effect |
|
Blood and lymphatic system disorders |
Thrombocytopenia Agranulocytosis |
|
Immune system disorders |
Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens Johnson syndrome/toxic epidermal necrolysis |
|
Respiratory, thoracic and mediastinal disorders |
Bronchospasm* |
|
Hepatobiliary disorders |
Hepatic dysfunction |
|
*There have been cases o: |
? bronchospasm with paracetamol, but these are |
more likely in asthmatics sensitive to aspirin or other NSAIDs.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
4.9 Overdose
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk Factors
If the patient
a. is on long term treatment with carbamazepine, phenobarbitone, phenytoin,
primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
Or
b. regularly consumes ethanol in excess of recommended amounts.
Or
c. is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N- acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Analgesic, Anilides ATC code: N02BE01 Mechanism of action
Paracetamol is an analgesic antipyretic and mild anti-inflammatory. The mechanism of action is probably similar to that of aspirin and dependent on the inhibition of prostaglandin synthesis. This inhibition appears, however, to be on a selective basis.
5.2 Pharmacokinetic properties
Absorption:
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is 1 - 4 hours after therapeutic doses. Paracetamol is metabolised in the liver and excreted in the urine, mainly as the glucuronide and sulphate conjugates.
A hydroxylated metabolite may accumulate and cause liver damage. Considerable “first pass” inactivation takes place in the gut wall and liver.
Distribution
Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 30% may be bound at the concentrations encountered during acute intoxication.
Elimination
Following therapeutic doses 90 - 100% of the drug may be recovered in the urine within the first day. However, practically no paracetamol is excreted unchanged and the bulk is excreted after hepatic conjugation.
Preclinical safety data
5.3
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Povidone
Starch
Magnesium Stearate Stearic Acid
6.2 Incompatibilities
Not applicable
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Containers: Do not store above 25°C. Keep the container tightly closed. Store in the original container.
Blister packs: Do not store above 25°C. Store in the original package. Keep container in the outer carton.
6.5 Nature and contents of container
Containers
High-density polystyrene containers with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polythene/polyurethane inserts. Pack sizes: 2, 4, 8, 12 and 16.
Blister pack
1. PVC/child-resistant push through foil (Paper/30p m soft Al laminated film with Al side heat sealed to PVC).
2. PVC/child-resistant composite film (15pm PVC/20pm Al). Pack sizes: 2, 4, 8, 12 and 16
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited
Boumpoulinas 11, 3rd Floor
NICOSIA
CYPRUS
P.C. 1060
CYPRUS
8 MARKETING AUTHORISATION NUMBER(S)
PL 33414/0076
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
03/08/2000 / 02/03/2009
10 DATE OF REVISION OF THE TEXT
28/10/2016